Method and device determine the threshold values for the volume and intensity of physical activity or the lowest levels that reduce risk factors in persons who suffer from disorders of sugar and lipid metabolism and are overweight. The method characterized in that the device registers a person's daily physical activity, compares it with the measured threshold levels and informs by its own or outside screen, if the volume and/or intensity of the physical activity has been sufficient to prevent the effects of disease risk factors. Based on this persons, who have disorders in sugar and lipid metabolism are able to perform physical activity maintaining health. The invention described herein demonstrates as a novel observation that even the low intensity physical activity will restrain risk factors related to cardiovascular diseases, diabetes and obesity.

1. A method for defining and presenting the threshold levels of physical activity observed to reduce blood cholestero!s and triglycerides and visceral fat in sedentary and overweight subjects suffering from disorders in sugar and/or lipid metabolisms. The method is characterized in that it utilizes transducer unit (2) and measuring system registering acceleration of an exercising a person with high risk of metabolic diseases (2). The method comprises

-a step (41,42, Fig.3), in which by the measuring unit accelerations of a body of person induced by physical activity are registered.

-a step (43)in which numbers of acceleration maxima within a certain time period are registered, stored and divided according to the magnitude to four classes,for estimating if the physical activity performed is promoting sugar, cholesterol and lipid metabolism;

- a step (44) in which a person's numbers of acceleration maxima in each acceleration class are compared to the reference data measured from exercising persons' numbers of acceleration maxima in each acceleration classes describing the level of physical activity known to improve sugar and fat metabolism;

- a step (45,46) in which by using the number of acceleration maxima in an acceleration class it is identified into which class describing the physical activity the person can be classified;

and

-a step (47) in which based on said class describing the physical activity performed it Is identified if the physical activity performed by the subject is beneficial for sugar, cholesterol and lipid metabolism (48,49)

2. The method according to the claim 1, characterized in that for a person whose physical activity exceeds the numbers of the highest class of the acceleration maxima or threshold in a given acceleration range is presented that the exercise performed has beneficial health effects on disorders in sugar cholesterol, and fat metabolism.

3. The method according to claim 2, characterized in that for defining the highest exercise activity class the registered acceleration maxima are divided into several acceleration classes between 0,3 and 10 g (0 g corresponds standing), usually into classes 0,3<0.5, 0.5<0.7,0.7<0.9, 0.9<1,1 and > 1,1. In high risk subjects over 80 % of the accelerations cluster between 0,3 and 0,7 g and was used in the analyses.

4. The method according to claim 3, characterized in that each measured acceleration maxima adds to the occurrence number (N) by one in the acceleration class to which it belongs.

5. The method according to the claim 4, characterized in that if the daily number of acceleration maxima exceeds the given threshold of 6520 daily steps within the acceleration range between 0,3 and 0,7 g, the person has performed physical activity, which is typically known to reduce blood cholesterol, LDL- cholesterol and triglycerides and visceral fat.

6. The transducer unit and accelerometer according to the claim 1, characterized in that an accelerometer comprises of one- or po!yaxia! device recording continuously accelerations induced by a person's physical activity

a processing unite and memory, which store and classify acceleration maxima into acceleration classes according to claim 3.

a memory unit, which typically compare numbers of classified acceleration maxima of the person with the given threshold level, exceeding of which is known to improve disorders of sugar and fat metabolism according to claim 5.

a processor unit, which gives information to a person, if his/her physical activity is promoting sugar and fat metabolism.

7. The transducer unit according to claim 6 characterized in that if the number of acceleration maxima performed by exceeds the given threshold level, a person is known to practice physical activity preventing disorders in sugar, cholesterol and fat metabolism.

8. The transducer unit according to the claim 7 characterized in that the maximum acceleration values are divided into the accelerations classes 0,3 <0,5, 0,5<0,7, 0,7<0.9, 0,9< 1,1 a d >l,lg.

9. The transducer unit according to the claim 8 characterized in that each registered maximum value of acceleration adds the occurrence by one (N=l) at the acceleration class it belongs to.

10 The transducer unit according to claim 9, characterized in that when the daily number of acceleration maxima exceeds the given threshold level 6250 in the acceleration range 0,3 - 0,7, the physical activity performed is known to reduce blood triglycerides, cholesterol, LDL-cholesterol and visceral fat

11. The transducer unit and/or external device according to claim 10, characterized in that they produce graphic and/or audiovisual presentation about the g-values, number of g-values, walking speed and energy expenditure on-line, as integrals of day, week or other time period and also information if the performed physical activity reach the given threshold level the exceeding of which is known to reduce blood cholesterol, LDL-cholesterol, triglycerides and visceral fat.

12. The transducer and acceleration units according to claim 2 can also be a cellular phone, by which a person's physical activity can be followed and steer so that physical activity is sufficient to reduce cholesterol, LDL-cholesterol, triglycerides and visceral fat.

13. The transducer unit according to claim 10 characterized in that is contains a code by which all he procedure presented in claims 1 - 5 can be performed.

The invention relates to a method and device for determining physical activity thresholds to improving sugar, cholesterol and fat metabolism in subjects who have sedentary life style. The use of motion sensors and transduction units to measure physical activity intensity and volume have been presented in US2008/0312560A1, WO02005117703. A method in which physical activity improving cholesterol metabolism in healthy subjects is presented in US 2010/0137107 Al.

The invention described here belongs to the medical discipline and includes the determination of physical activity thresholds that can be used for preventing risks for metabolic diseases such as diabetes and cardiovascular disease by reducing blood cholesterol, triglycerides and visceral fat mass. The earlier invention purposed for healthy subjects related to physical activity reducing blood cholesterol (US 2010/0137107 Al) is not suitable to subjects who have risks of diabetes and/or cardiovascular diseases, as they are not capable to perform prescribed physical activity previously shown to reduce blood cholesterol in healthy subjects (Herzig et al. 2014 Int J Obesity38:1089).

The background of the invention

Overweight and metabolic diseases increase significantly in industrialized countries in which energy rich diets are widely used and energy expenditure remains low. According to the WHO statistics over 1,400,000,000 of the world population are overweight or obese, Overweight and low physical activity result in an increase in the prevalence of metabolic diseases mainly diabetes and cardiovascular diseases. It is currently estimated that 500,000,000 of the population suffer from type 2 diabetes and the number will be doubled by the year 2030. In addition atherosclerosis, calcification of blood vessels, due to sedentary life style exposes to deaths for cardiovascular diseases being the most frequent death causes in industrialized countries. The dead roll is presently 15,000,000 annually and is growing every year. Low levels of physical activity is also a dangerous risk factor disability-adjusted life years. According to the present WHO statistics it is annually responsible for 1,000,000 death cases and loss of 8,000,000 disability- adjusted life years. Official guidelines for physical activity promoting health

The present physical activity recommendations of WHO, American Diabetes Association and American Heart Association state that healthy adults should perform at least 150 min moderate intensity physical activity every week such as walking at the speed of 5 km/h. This threshold should imply walking 2 km or 3000 steps within 20 min during all days of the week. These recommendations have been developed by reviewing subjects about their physical activity levels and demonstrated that about 50% of the adult population met the guidelines. Later physical activity levels have been studied objectively by accelerometers and the results showed that only less than 5 % of the adult population will meet the above- mentioned official guidelines of physical activity. Therefore all the previous studies about the health effects of physical activity using personal reviews or questionnaires are questionable.

CORRECTED VERSION Physical activity and risks for diabetes, cardiovascular and metabolic diseases

Calcification of blood vessels, high blood sugar, cholesterol and triglycerides are risk factors for diabetes and cardiovascular diseases. These risk factors can be reduced by increased physical activity and weight reduction programs. Increased exercise will lead to decreases in blood LDL-cholesterol and increases HDL- cholesterol (Tannescu et a. 2002 JAMA, 288,1994, Kraus et ai. 2002, NEJM 347, 1483) all reducing risks of cardiovascular diseases. In a similar way increased weekly exercise and weight reduction programs prevented developing of the type 2 diabetes in 60 % of patients (Tuomilehto et a!. 2002,NEJM 304.1343, Knowler et al. 2002, NEJM 346:393). Fat tissues especially those around the internal organs are body ' s energy sources and are released to blood circulation during exercises. It has been shown that during exercises fat from the internal organs is first mobilized and starts the reduction of body weight (O'Leary et al. 2009, J Appl Physiol 100,1958).

The results of scientific studies demonstrate that increased physical activity is effective in preventing risk factors of diabetes and cardiovascular diseases and is an important vehicle in weight reduction. However, in none of these cited or other previous studies the exact amounts and intensities of physical activity preventing diabetes or cardiovascular diseases have been described. Our research groups is the only one that have measured physical activities by objective methods in order to find out beneficial effects of disease risk factors. Our main goal has been to define the minimum amounts and intensities or threshold levels which will reduce the risks for diabetes and cardiovascular diseases. By using our accelerometer we have previously demonstrated that blood cholesterol decreases by 15 % in healthy women as the number of daily steps exceeded 1000 at acceleration of 2.2 g corresponding to walking at the speed of 5 km/h (VainionpSS et al. 2007, Me Sci Sport Exerc 39,756).

Scientific research related to the invention

In our study related directly to this intervention we observed that i n overweight subjects having abnormal sugar balance clearly lower intensity levels of physical activity than those given in the official physical activity recommendations reduced risks for diabetes and cardiovascular diseases (Herzig et al.2014, Int J Obesity 38:1089). Walking at accelerations of 0.3 - 0.7 g corresponding to the walking speed of 2 -3 km/h led to decreases in blood triglycerides and cholesterols (Fig 1A) and visceral fat (Fig IB) as the number of daily steps exceeded 6520. This was a very important finding, since most overweight subjects suffering from abnormal blood glucose are not able to walk at the speed of 5 km/h required in the present official recommendations. Therefore most of these subjects do not follow the present recommendations. Our accelerometer recording amounts and Intensities made it possible to determine exact threshold levels of physical activity promoting health to be used in the reduction of risk factors of metabolic diseases.

To which problem does our invention offer the best solution?

High occurrence of overweight, obesity, diabetes and cardiovascular diseases in the populations of industrialized countries are major health problems. Precise physical activity guidelines are not available in adequately targeting these health problems. Our present intervention offers exact information about amounts and intensities of physical activity resulting in reduction of risks for diabetes and cardiovascular diseases and visceral fat. Previous solutions

Before our present invention there was no information about the exact amount and intensity of physical activity reducing risk factors of diabetes and cardiovascular diseases in subjects suffering from metabolic disorders. The present physical activity guidelines (WHO, American Diabetes Association and American Heart Association} are based on questionnaires and reviews from healthy subjects and are too demanding for most general subjects often having overweight and suffering from metabolic disorders. Blood sugar and cholesterol levels have been previously followed by motion sensors in subjects who have abnormal blood glucose but the sensors have been used only for the following of the physical activity but not for the studies of health effects (Yates et al. 2009, Diabetes care 32:1404, Saito et al. Ann Intern Med 2011, 171,1352). In healthy subjects the amounts and intensities of physical activity reducing blood cholesterol (Vainionpaa et al. 2007, Med Sci Sports Exerc.39,756, US patent 2008/0312560 Al) have been solved by accelerometers detecting number of steps and intensity (g-values). in the same subjects the amount and intensity of the physical activity preventing osteoporosis was solved (Vainionpaa et a. 2006, Int J Osteoporosis 17,455, US patent, US 2010137107 Al). It should be noted that both studies deal on the same subjects, to whom physical activity thresholds reducing cholesterol and preventing osteoporosis could be defined simultaneously by the accelerometer.

The invention described here manages physical activity thresholds reducing blood cholesterol, triglycerides and visceral fat in overweight subjects with metabolic disorders. These subjects are not able to reach physical activity thresholds presented in the patent (US 20107137107), and therefore they need their own physical activity thresholds. The patents US 2008/0312560 Al and US 2010/137107 Al and the one described here belong to the same patents family, in which determining of physical activity thresholds are novel and differ from the previously known techniques

Accelerometers (patents US 2010191155 Al, EP 0700661 A2, US 2009171614 Al, EP 2210557 Al and US 2001049470 Al) and a heart rate monitor (US 20110213) have been previously used for measuring energy expenditure of physical activity or following body weight and nutrient intake in healthy subjects and heart rate monitor for protein consumption and recovery In athletes, It should be noted that all the above mentioned methods measuring energy expenditure are useless for establishing threshold levels improving health. For instance in a previous study we demonstrated that walking 12982 daily steps at the acceleration range 0,3 - 1,0 g had no effect on blood cholesterol, whereas 1062 daily steps at the acceleration range 1,1-2,4 g reduced blood cholesterol by 15 % (Vainionpaa et al. 2007, Med Sci Sports Exerc 39,756). 12982 daily steps at 0.3 - 1.0 g stand for 10 MET-units, but 1062 daily steps at 1.1 - 2.4. stand for 1 MET-unit. We therefore conclude that energy expenditure in MET-units or calories which have been used in the above mentioned patents, neither relate to determining thresholds nor health benefits of physical activities in sedentary subjects.

Advantages of the invention described Our invention has many advantages. It makes it possible to determine for the first time the volume and intensity of the physical activity threshold reducing disease risks in subjects, who are sedentary, have overweight and suffer from metabolic disorders. These subjects cover approximately 50 % of the population and previously there have not been any physical activity recommendations for them. The acce!erometer described in the intervention can be easily used continuously making it possible to register all types of physical activity including habitual activities. This will make it easy to meet our novel physical activity recommendations. From the point of preventive medicine walking is also the best form of physical activity. It activates the biggest muscles in the body and its energy expenditure can be accurately measured by accelerometers recording number of steps and step induced accelerations or walking speeds. Maintaining walking ability protects also from falling accidents and hospitalization.

High occurrence of overweight, obesity and metabolic disorders in the present populations and the information of the preventive characteristics and efficacy of the invention described here will offer large possibilities to its extensive use and to commercial adaptations.

The methods of the Invention

The results presented in fig.lA and IB are derived from 68 subjects carrying accelerometer for 3 months. The subjects were overweight men and women aged 30-70 years and had abnormal blood sugar. One half of the subjects participated in supervised exercise weekly and the other half continued their normal life style. The subjects carried accelerometers during wake-full time on their waist. The acceleration values their daily numbers were continuously registered. Blood samples were taken at the beginning and end of the trial to measure blood sugar, Insulin, cholesterol, LDL-cholesterol and triglycerides. The amount of the visceral fat was measured by a bio-impedance method. The distribution of the accelerations during 3 months showed that exercises increased significantly number of steps or impacts in the acceleration classes 0.3 - 0.7 g, corresponding typically to slow walkin 2-3 km/h. The steps in the acceleration class 0.3 - 0.7 were divided by their magnitudes to quartiles. Cholesterol and fat concentrations between each quartile were analyzed. The results showed (fig 1A and IB) that total cholesterol, LDL-cholesterol, triglycerides and visceral fat in the fourth quartile (over 6520 daily steps) were significantly lower than in the other quartiles. 6520 daily steps is the threshold for physical activity, the exceeding of which reduced total cholesterol by 0.6 mmol/l, LDL-cholesterol 0.7 mmol/l, triglycerides 0.4 mmol/l and the area of visceral fat by 12%. Our results show that physical activity volume and intensity measured by the invention described herein explain beneficial health effects observed in cholesterol and triglyceride concentrations and in visceral fat. Corresponding results in subjects with sedentary life style have not been able to obtain by using previous methods.

The invention described herein does essentially differ from the previously known methods by which exercises have been used for prevention of risk factors of diabetes and cardiovascular diseases. Physicians have generally been aware about the beneficial effects of regular exercise, but the volume, intensity and duration of the exercises have been unknown. It was novel and unexpected in our invention that in sedentary subjects physical activity of very low intensity (accelerations 0.3 - 0.7 g) reduced concentrations of the major risk factors of diabetes and cardiovascular diseases. Our invention is also different form other patents and recommendations, since those do not take low intensity exercise into account.